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Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure

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ClinicalTrials.gov Identifier: NCT00716001
Recruitment Status : Unknown
Verified July 2008 by Osaka General Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2008
Last Update Posted : July 15, 2008
Sponsor:
Information provided by:
Osaka General Medical Center

Study Description
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Brief Summary:
This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Drug: N-acetylcysteine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : July 2008
Estimated Primary Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: NAC Drug: N-acetylcysteine
Placebo Comparator: nonNAC Drug: N-acetylcysteine


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with chronic renal failure(serum creatinine >1.1mg/dl) undergoing elective percutaneous coronary intervention

Exclusion Criteria:

  • administered with sodium bicarbonate and/or N-acetylcysteine and/or contrast media within 72 hours.
  • pregnancy
  • congestive heart failure
  • allergy to sodium bicarbonate and/or N-acetylcysteine
  • hemodialysis
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Masaharu Masuda, Osaka General Medical Center
ClinicalTrials.gov Identifier: NCT00716001    
Other Study ID Numbers: OPTSB
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: July 15, 2008
Last Verified: July 2008
Keywords provided by Osaka General Medical Center:
patients with chronic renal failure undergoing elective percutaneous coronary intervention
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes